Principal Scientist, Synthetics Analytics (Peptides & Oligos)

HiTalento TALENTO ApS; København; Híbrido; DKK 1.000.000 - 1.500.000; Jornada completa

Descripción de la vacante

Hemab Therapeutics, based in Copenhagen and Cambridge, seeks a Principal Scientist - Analytical Development, Synthetics to lead analytical strategy for synthetic therapeutics (peptides/oligonucleotides) from first-in-human to commercial readiness.

You will drive method development/validation, QC, and regulatory submissions (NDAs/MAAs), and oversee CROs/CDMOs across time zones to ensure smooth progression to commercialization.

Formación

• Extensive experience setting analytical strategy for synthetic therapeutics (peptides/oligos).
• Late-stage development through commercialization exposure.
• Experience with external CDMOs/CDRMs and regulatory submissions.
• Independent analytical expert capable of leading cross-functional teams.

Responsabilidades

• Own analytical strategy for synthetics programs, peptides and oligonucleotides, from first-in-human through commercial readiness.
• Establish phase-appropriate analytical approaches, including specifications, characterization, impurities, reference standards and stability.
• Provide technical input to CDMOs on method development and validation (purity methods).
• Manage analytical method transfer, optimization and validation with external partners for commercial readiness.
• Ensure mechanism of action-based potency assay if needed for Phase 3 readiness.
• Provide analytical expertise on CMC sub-teams across Drug Substance/Product, Q&R.
• Support process characterization and validation of In-Process Controls.
• Lead and manage CROs/CDMOs, suppliers, vendors; monitor regulatory trends and costs.
• Author/regulatory submissions for NDAs/MAAs as analytical lead.

Conocimientos

Analytical strategy

Synthetics expertise

CRO/CDMO mgmt

Regulatory submissions

ICH stability knowledge

Educación

PhD in relevant field

Descripción del empleo

Hemab Therapeutics, based in Copenhagen and Cambridge, seeks a Principal Scientist - Analytical Development, Synthetics to lead analytical strategy for synthetic therapeutics (peptides/oligonucleotides) from first-in-human to commercial readiness.

You will drive method development/validation, QC, and regulatory submissions (NDAs/MAAs), and oversee CROs/CDMOs across time zones to ensure smooth progression to commercialization.